– Oral sebetralstat regimen for short-term prophylaxis to be evaluated in KONFIDENT-S –

– Positive phase 1 sebetralstat data supports KONFIDENT trial expansion to Japan –

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today presented three posters at the Western Society of Allergy, Asthma & Immunology 60th Annual Scientific Session in Kona, HI.

The first highlighted that KONFIDENT-S (NCT05505916) is a prospective trial to evaluate the effectiveness and safety of sebetralstat, an investigational oral plasma kallikrein inhibitor, for short-term prophylaxis (STP). The second reported phase 1 data evaluated the pharmacokinetic and pharmacodynamic parameters of sebetralstat in Japanese adults. These positive Phase 1 data support the expansion of the KONFIDENT (NCT05259917) phase 3 trial to Japan. Finally, KalVista presented a post hoc analysis of phase 2 trial data demonstrating that sebetralstat provided similar symptom relief, reduction in attack severity, and use of rescue regardless of abdominal or peripheral attack location.

• Targeted Literature Review to Assess the Studies Supporting Short-term Prophylactic Treatment Options for the Preprocedural Prevention of Attacks in Patients With Hereditary Angioedema: Dr. Marc A. Riedl, Division of Rheumatology, Allergy and Immunology, University of California San Diego, US

• Pharmacokinetic, Pharmacodynamic, and Safety Profile of Sebetralstat in Healthy Japanese and White Adults: Results From a Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial: Matthew Iverson, KalVista Pharmaceuticals Inc., Cambridge, MA, USA

• Efficacy of the Oral Plasma Kallikrein Inhibitor Sebetralstat (KVD900) by Attack Location in a Phase 2 Clinical Trial in Patients With Hereditary Angioedema: Dr. Paul K. Audhya, KalVista Pharmaceuticals Inc., Cambridge, MA, USA

Links to all posters and presentations can be found on the KalVista website under “Publications”.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.

For more information about KalVista, please visit www.kalvista.com.

For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT trial, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2022, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230207005607/en/